Ambient shipping of immobilized mRNA on dermal biomarker patches

Summary: RNA stability is central to processing of samples in the laboratory and the central dogma is that stability is difficult to achieve. This is further exacerbated by the fact that the clinics are located in different geographies, have different collection personnel, ambient temperatures and variation in shipping handling. These factions have a direct impact on the quality and stability of collected mRNA samples. Data from our collections using the Mindera Health Dermal Biomarker Patch (DBP) have displayed longer than expected stability at 2-8°C of up to 14 days without showing a discernible effect on assay result. This indicates that the binding to the DBP in combination with the storage buffer has a protective function on the attached mRNA. The purpose of this study was to evaluate the stability of RNA in transit from collection site to the laboratory in various conditions and ambient temperatures. Previous evaluation of this theory within the laboratory environment demonstrated that samples were stable in the range from -20°C to +40°C with current stabilization buffer as well as a modified buffer. To evaluate this further and in real world conditions, a clinical study was initiated. The study was performed by collection of 3 samples from each of 200 patients at 4 independent sites throughout the US over a period of 2 months. The first sample was returned under the current shipping mechanism, chilled and priority overnight. The second and third samples used the same collection buffer or modified buffer, respectively, and returned using 2-day shipping and at ambient conditions. Quantity and quality of collected RNA was assessed using insert size as a measure of integrity. Good parity was observed between the three samples within patients, despite significant variations in shipping conditions. As previously observed with the DBP platform, a range of RNA concentration was obtained, however, all samples yielded interpretable data by RNA-Seq. The results suggest that the binding of RNA to the DBP imparts sufficient stability to allow for ambient shipping. George Penman¹, Jazmin Avalos¹, Jaryl-Ayana Gutierrez¹, Eric Gordon¹, Eric Andrade¹, David De Los Santos¹, Paul Montgomery¹, Tobin Dickerson¹ 1. Mindera Corporation, Vista, CA, United States. Translational Studies: Preclinical